Prosthetic heart valves

ABSTRACT

Prosthetic heart valves may be delivered to a targeted native heart valve site via one or more delivery catheters. In some embodiments, the prosthetic heart valve includes structural features that securely anchor the prosthetic heart valve to the anatomy at the site of the native heart valve. Such structural features can provide robust migration resistance. In addition, the prosthetic heart valves can include structural features that improve sealing between the prosthetic valve and native valve anatomy to mitigate paravalvular leakage. In particular implementations, the prosthetic heart valves occupy a small delivery profile; thereby facilitating a smaller delivery catheter system for advancement to the heart. Some delivery catheter systems can include a curved inner catheter to facilitate deployment o the prosthetic heart valve to a native tricuspid valve site via a superior vena cave or inferior vena cave.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional application of U.S. patent applicationSer. No. 17/986,597 filed on Nov. 14, 2022, which claims the benefit ofU.S. Provisional Application Ser. No. 63/390,810 filed on Jul. 20, 2022.The disclosure of the prior applications are considered part of (and areincorporated by reference in) the disclosure of this application.

FIELD OF INVENTION

This disclosure generally relates to prosthetic heart valve systems. Forexample, this disclosure relates to transcatheter deliverable prostheticheart valves that are adapted to be used to replace a sub-optimallyfunctioning native heart valve, including but not limited to a tricuspidvalve.

BACKGROUND

A human heart includes four types of heart valves that are arranged toensure blood flow in specific directions: mitral, tricuspid, aortic andpulmonary valves. The aortic and pulmonary valves are semilunar valves,which are in the arteries leaving the heart, and prevent blood fromflowing back into left ventricle and right ventricle respectively whenclosed. The mitral and tricuspid valves are atrio-ventricular valves,which are between the atria and the ventricles, and prevent blood fromflowing back into left atrium and right atrium respectively when closed.Conditions of stenosis (when valve does not open fully) as well asregurgitation/insufficiency (when valve does not dose properly resultingin leaks) are recognized as significant contributors to mortality andmorbidity.

Some valve replacement systems include valve prostheses that arecompressed into a delivery catheter, also referred to as transcathetervalves, so as to avoid open-heart surgery. Many transcatheter valveprostheses have a tubular frame that may or may not be axisymmetric, andinclude two or more leaflets. While these transcatheter valve prosthesescan be compressed into a catheter, they may still require a largedelivery system (for example, a required catheter size of 45 French).This is especially true in case of mitral valve replacement systems andtricuspid valve replacement systems, which often require valveprostheses with a larger profile.

SUMMARY

Some embodiments described herein include a prosthetic heart valve thatmay be delivered to a targeted native heart valve site via one or moredelivery catheters. In some embodiments, a prosthetic heart valveincludes structural features that securely anchor the prosthetic heartvalve to the anatomy at the site of the native heart valve. Suchstructural features can provide robust migration resistance. Inaddition, the prosthetic heart valves can include structural featuresthat improve sealing between the prosthetic valve and native valveanatomy to mitigate paravalvular leakage. In particular implementations,the prosthetic heart valves occupy a small delivery profile, therebyfacilitating a smaller delivery catheter system for advancement to theheart. Some delivery catheter systems can include a curved innercatheter to facilitate deployment of the prosthetic heart valve to anative tricuspid valve site via a superior vena cava or inferior venacava.

In one aspect, this disclosure is directed to a prosthetic heart valvethat includes a main body comprising an inflow end portion and anoutflow end portion, and an occluder extending between the inflow endand outflow end portions and comprising valve leaflets attached to themain body in an arrangement that: (i) allows blood flow through theoccluder in a direction from the inflow end portion toward the outflowend portion along a central axis of the occluder and (ii) prevents bloodflow through the occluder in a direction from the outflow end portiontoward the inflow end portion. The prosthetic heart valve also includesa first anterior flap extending from the outflow end portion in a firstdirection that is transverse to the central axis; a posterior flapextending from the outflow end portion in a second direction that isopposite of the first direction; and posterior arm extending from theinflow end portion in the second direction.

Such a prosthetic heart valve may optionally include one or more of thefollowing features. The prosthetic heart valve may also include ananterior arm extending from the inflow end portion in the firstdirection. The prosthetic heart valve may also include a second anteriorflap extending from the outflow end portion in the first direction. Thefirst and second anterior flaps may overlap each other. Across-sectional shape of the first and second anterior flaps takenperpendicularly to the first direction may be arcuate.

In another aspect, this disclosure is directed to another prosthetichead valve. The prosthetic heart valve includes a main body comprisingan inflow end portion and an outflow end portion; and an occluderextending between the inflow end and outflow end portions and comprisingvalve leaflets attached to the main body in an arrangement that: (i)allows blood flow through the occluder in a direction from the inflowend portion toward the outflow end portion along a central axis of theoccluder and (ii) prevents blood flow through the occluder in adirection from the outflow end portion toward the inflow end portion.The prosthetic head valve also includes an anterior flap extending fromthe outflow end portion in a first direction that is transverse to thecentral axis; a posterior flap extending from the outflow end portion ina second direction that is opposite of the first direction; and ananterior arm extending from the inflow end portion in the firstdirection.

In another aspect, this disclosure is directed to another prosthetichead valve. The prosthetic heart valve includes a main body comprisingan inflow end portion and an outflow end portion, and an occluderextending between the inflow end and outflow end portions and comprisingvalve leaflets attached to the main body in an arrangement that: (i)allows blood flow through the occluder in a direction from the inflowend portion toward the outflow end portion along a central axis of theoccluder and (ii) prevents blood flow through the occluder in adirection from the outflow end portion toward the inflow end portion.The prosthetic heart valve also includes a first anterior flap extendingfrom the outflow end portion in a first direction that is transverse tothe central axis; and a second anterior flap extending from the outflowend portion in the first direction. A cross-sectional shape of the firstand second anterior flaps taken perpendicularly to the first directionis arcuate from an outer edge of the first anterior flap to an outeredge of the second anterior flap.

In another aspect, this disclosure is directed to another prostheticheart valve. The prosthetic heart valve includes a main body comprisingan inflow end portion and an outflow end portion, and an occluderextending between the inflow end and outflow end portions and comprisingvalve leaflets attached to the main body in an arrangement that: (i)allows blood flow through the occluder in a direction from the inflowend portion toward the outflow end portion along a central axis of theoccluder and (ii) prevents blood flow through the occluder in adirection from the outflow end portion toward the inflow end portion.The prosthetic heart valve also includes a first anterior flap extendingfrom the outflow end portion in a first direction that is transverse tothe central axis; a second anterior flap extending from the outflow endportion in the first direction; a first posterior flap extending fromthe outflow end portion in a second direction that is opposite of thefirst direction; and a second posterior flap extending from the outflowend portion in the second direction. A passageway is defined between thefirst and second posterior flaps. The first and second posterior flapsextend from the outflow end portion farther than the first and secondanterior flaps.

In another aspect, this disclosure is directed to a method of deployinga prosthetic heart valve. The method includes engaging any of theprosthetic heart valves described herein with anatomical structures of anative tricuspid valve. The lateral anterior flap extends into a rightventricular outflow tract (RVOT) and engages with a lateral wall of theRVOT to provide anchoring during diastole.

In another aspect, this disclosure is directed to another method ofdeploying a prosthetic heart valve. The method includes engaging any ofthe prosthetic heart valves described herein with anatomical structuresof a native tricuspid valve. A distal end portion of the posterior armrests against an interior wall of an inferior vans cava, or coronarysinus, or a right atrium.

In another aspect, this disclosure is directed to another method ofdeploying a prosthetic heart valve. The method includes engaging any ofthe prosthetic heart valves described herein with anatomical structuresof a native tricuspid valve. A distal end portion of the anterior armrests against an interior, wall of a right atrial appendage.

Various types of deployment systems may be used in combination with theprosthetic tricuspid valves described herein. In some embodimentsdescribed herein, such a deployment system may include an outer sheathcatheter defining a first lumen; a middle deflectable catheter slidablydisposed in the first lumen and defining a second lumen, the middledeflectable catheter comprising a selectively deflectable distal endportion with at least one plane of deflection; and an inner controlcatheter slidably disposed in the second lumen and including one or morecontrol wires that configure the inner control catheter to releasablycouple with a prosthetic heart valve. The inner control catheterincludes a distal end portion that elastically transitions to anaturally curved configuration when the inner control catheter convertsfrom being radially constrained to being radially unconstrained. In someembodiments, the distal end portion defines an interior anole of lessthan 135 degrees when in the naturally curved configuration.

In another aspect, this disclosure is directed to another method ofdeploying a prosthetic heart valve. The method includes advancing theprosthetic heart valve toward a native tricuspid valve, via a jugularvein and a superior vena cava, while the prosthetic heart valve isreleasably coupled to a prosthetic heart valve deployment system anddiametrically constrained in a low profile delivery configuration. Theprosthetic heart valve deployment system includes an outer sheathcatheter defining a first lumen; a middle deflectable catheter slidablydisposed in the first lumen and defining a second lumen, the middledeflectable catheter comprising a selectively deflectable distal endportion; and an inner control catheter slidably disposed in the secondlumen and including one or more control wires that are releasablycoupled with the prosthetic heart valve. The inner control catheterincludes a distal end portion constrained in the first lumen. The methodalso includes retracting the outer sheath relative to the inner controlcatheter to allow the distal end portion of the inner control catheterto become radially unconstrained and to elastically transition to acurved configuration; and deflecting the selectively deflectable distalend portion of the middle deflectable catheter so that the inner controlcatheter and the middle deflectable catheter in combination are curvedby at least 90° relative to the outer sheath.

In another aspect, this disclosure is directed to another method ofdeploying a prosthetic heart valve. The method includes advancing theprosthetic heart valve toward a native tricuspid valve, via a femoralvein and an inferior vena cava, while the prosthetic heart valve isreleasably coupled to a prosthetic heart valve deployment system anddiametrically constrained in a low profile delivery configuration. Theprosthetic heart valve deployment system includes an outer sheathcatheter defining a first lumen; a middle deflectable catheter slidablydisposed in the first lumen and defining a second lumen, the middledeflectable catheter comprising a selectively deflectable distal endportion; and an inner control catheter slidably disposed in the secondlumen and including one or more control wires that are releasablycoupled with the prosthetic heart valve. The inner control catheterincludes a cured distal end portion that is curved by less than 20° whenconstrained in the first lumen. The method also includes advancing theinner control catheter relative to the outer sheath to allow the curveddistal end portion to become unconstrained and to elastically transitionto a curved configuration that is curved by at least 45° relative to theouter sheath; and deflecting the selectively deflectable distal endportion of the middle deflectable catheter so that the inner controlcatheter and the middle deflectable. catheter in combination are curvedby at least 90° relative to the outer sheath.

In another aspect, this disclosure is directed to a method of deployinga prosthetic heart valve (such as any of the prosthetic heart valvesdescribed herein). The method Includes deployment of a lateral anteriorflap of the prosthetic heart valve such that the lateral anterior flapextends into a right ventricular outflow tract (RVOT) and engages with alateral wall of the RVOT. In that position, there can be lateral walltissue present on both sides of the lateral anterior flap (e.g., on thesuperior side and the inferior side, or on the atrial directional sideand the ventricular directional side) to provide anchoring duringdiastole.

Any of the prosthetic heart valves described herein may optionallyinclude one or more of the following additional features. In someembodiments, portions of the first anterior flap and the second anteriorflap overlap each other. The prosthetic tricuspid valve may also includea posterior flap extending laterally from the end of the main body in anopposite direction as the first and second anterior flaps. In someembodiments, the first and second anterior flaps extend fartherlaterally than the posterior flap. In particular embodiments, the firstand second anterior flaps in combination are wider (in the septal tolateral direction) than the posterior flap. A framework of theprosthetic tricuspid valve (that comprises the main body, the first andsecond anterior flaps, and the posterior flap) may be made of a single,unitary material that was cut and expanded. In some embodiments, adistal tip portion of the posterior flap extends along an axis that isat a non-zero angle relative to a portion of the posterior flap thatextends directly from the main body. In some examples, having theportions of the first anterior flap and the second anterior flap thatoverlap each other increases a bending resistance of the first anteriorflap and the second anterior flap in combination as compared to thefirst anterior flap and the second anterior flap individually. Havingthe portions of the first anterior flap and the second anterior flap asseparate members can configure the prosthetic tricuspid valve to have apacemaker lead pass through the prosthetic tricuspid valve between thefirst and second anterior flaps. The prosthetic tricuspid valve may alsoinclude one or more additional anterior flaps extending laterally fromthe end of the main body in the same direction as the first and secondanterior flaps. The prosthetic tricuspid valve may also include two ormore posterior flaps extending laterally from the end of the main bodyin an opposite direction as the first and second anterior flaps. Havingthe portions of the first posterior flap and the second posterior flapas separate members can configure the prosthetic tricuspid valve to havea pacemaker lead pass through the prosthetic tricuspid valve between thefirst and second posterior flaps. In some embodiments, a transversecross-section of the main body has an oval shaped outer profile thatdefines a major diameter and a minor diameter. The minor diameter isshorter than the major diameter. The occluder may have a circularcross-sectional shape, and the anterior and posterior flaps may extendtransversely to the major diameter. The prosthetic heart valve may alsoinclude a leaflet engagement member extending from the main body, aportion of the leaflet engagement member extending toward the inflow endportion and terminating at a free end. The leaflet engagement member mayextend in the second direction, The posterior flap may extend fartheraway from the main body than the leaflet engagement member.

BRIEF DESCRIPTION OF FIGURES

FIG. 1 shows a sectional view of a human heart including four heartvalves (mitral valve, tricuspid valve, aortic valve, and pulmonaryvalve) that allow blood flow through specific pathways. The mitral andtricuspid valve are arranged to prevent backflow of blood into leftatrium and right atrium respectively when the left and right ventriclecontract respectively.

FIG. 2 shows a top view of the tricuspid valve of FIG. 1 and includingthree native leaflets: anterior, posterior and septal.

FIG. 3 shows another sectional view of a human heart including the fourchambers (right atrium, right ventricle, left atrium, and leftventricle) and major conduits that deliver blood to the heart andtransport blood away from the heart.

FIG. 4 shows a schematic view of the right side of the heart of FIG. 3 ,including the right atrium (“RA”), right ventricle (“RV”), and rightventricle outflow tract (“RVOT”), in accordance with some nativeanatomies.

FIG. 5 shows another schematic view of the right side of the heart ofFIG. 3 , including the RA, RV, and RVOT, in accordance with some nativeanatomies.

FIG. 6 shows a side view of an example prosthetic heart valve inaccordance with some embodiments described herein.

FIG. 7 shows a side view of the prosthetic heart valve of FIG. 6 engagedwithin a native tricuspid valve.

FIG. 8 shows a top view of the prosthetic heart valve of FIG. 6 .

FIG. 9 shows a top view of a frame of another example prosthetic heartvalve in accordance with some embodiments described herein.

FIG. 10 schematically illustrates a transverse plane view of a nativetricuspid valve annulus and RVOT.

FIG. 11 schematically illustrates a top view of the prosthetic heartvalve of FIG. 6 .

FIG. 12 schematically illustrates the prosthetic heart valve of FIG. 11engaged with the native tricuspid valve annulus and RVOT of FIG. 10 .

FIG. 13 schematically illustrates a cross-section view taken along thecutting plane 13-13 of FIG. 12 and including the anterior flaps of theprosthetic heart valve and the RVOT.

FIG. 14 schematically shows a longitudinal plane cross-section view ofan anterior portion of a native tricuspid valve annulus and the anteriorflaps of prosthetic heart valves described herein.

FIG. 15 is an anterior side view of the prosthetic heart valvesdescribed herein showing a cross-sectional shape of the anterior flaps.

FIG. 16 shows a top view of some prosthetic heart valves describedherein.

FIG. 17 shows a plan view of an example prosthetic heart valvedeployment system in accordance with some embodiments.

FIG. 18 shows an expanded view of a distal end portion of the prostheticheart valve deployment system of FIG. 17 .

FIG. 19 schematically illustrates a side view of the prosthetictricuspid valves described herein.

FIG. 20 schematically shows the prosthetic tricuspid valve of FIG. 19coupled with the prosthetic heart valve deployment system of FIG. 17 .

FIGS. 21 through 30 show an example trans-jugular method of deployingthe prosthetic tricuspid valves described herein using the prostheticheart valve deployment system of FIG. 17 .

FIG. 31 schematically shows a top view of another example prostheticheart valve in accordance with some embodiments described herein.

FIGS. 32-37 schematically depict an example trans-femoral method ofdeploying the prosthetic heart valve of FIG. 31 using the prostheticheart valve deployment system of FIG. 17 .

FIG. 38 is a perspective view of an example frame that can be used forthe prosthetic heart valves described herein.

FIG. 39 is a top view of the frame of FIG. 38 .

FIG. 40 is a side view of the frame of FIG. 38 .

FIG. 41 is a perspective view of another example frame that can be usedfor the prosthetic heart valves described herein.

FIG. 42 is a top view of the frame of FIG. 41 .

FIG. 43 is a side view of the frame of FIG. 41 .

DETAILED DESCRIPTION

Some embodiments described herein include a prosthetic head valve thatmay be delivered to a targeted native heart valve site via one or moredelivery catheters. In some embodiments, a prosthetic heart valveincludes structural features that securely anchor the prosthetic heartvalve to the anatomy at the site of the native heart valve. Suchstructural features can provide robust migration resistance duringdiastole and systole. In addition, the prosthetic heart valves caninclude structural features that improve sealing between the prostheticvalve and native valve anatomy to mitigate paravalvular leakage. Inparticular implementations, the prosthetic heart valves occupy a smalldelivery profile, thereby facilitating a smaller delivery cathetersystem for advancement to the heart. Some catheter-based prostheticheart valve deployment systems can include a curved inner catheter tofacilitate deployment of the prosthetic heart valve to a nativetricuspid valve site via a super or vena cave or inferior vena cava.

Referring to FIG. 1 , certain aspects of the concepts described hereinregarding the heart valve replacement systems can be implemented inprosthetic valve designs that are intended for use at any of the fourheart valves that allow blood flow through a specific pathway: mitralvalve, tricuspid valve, aortic valve and the pulmonary valve. FIG. 2depicts, for example, a targeted site at a tricuspid valve 10 of theheart. The tricuspid valve 10 includes, an anterior leaflet 11 a, aposterior leaflet 11 p, and a septal leaflet 11 s; and an annulus 12. Insome circumstances, the tricuspid valve 10 may undergo stenosis oranatomical changes that cause tricuspid regurgitation, such as instancesin which the distance between the anterio-septal commissure and theanterio-posterior commissure of the native tricuspid valve increaseswith the progression of a diseased state due to dilation of the annulus12 of the tricuspid valve 10.

FIG. 3 illustrates a longitudinal sectional view of a human heart 1 thatshows the four chambers (right atrium, right ventricle, left atrium, andleft ventricle) and the major conduits that deliver blood to the heart 1and transport blood away from the heart 1. The tricuspid valve 10 islocated between the right atrium and the right ventricle. Blood entersthe right atrium from the superior vena cava and the inferior vena cava.Blood flows from the right atrium to the right ventricle through thetricuspid valve 10. The blood exits the right ventricle and enters themain pulmonary artery (“MPA”) via the RVOT that is adjacent to thetricuspid valve 10.

FIGS. 4 and 5 schematically illustrate the right side of the heart 1,including the right atrium, right ventricle, and tricuspid valve 10therebetween. Naturally, there is anatomical variability among the humanpopulation. FIGS. 4 and 5 depict some of the anatomical variability. Inparticular, FIG. 4 shows a heart la that includes the presence of aposterior shelf 11. In contrast, FIG. 5 shows a heart 1 b with a lack ofany such posterior shelf. Some human hearts (such as the heart 1 a) havea posterior shelf 11, but some human hearts (such as the heart 1 b) donot have a distinct posterior shelf. The prosthetic tricuspid valvesdisclosed herein are designed to be implantable in the native tricuspidvalve 10 of both types of anatomies (e.g., both the heart 1 a with theposterior shelf 11, and the heart 1 b without the posterior shelf).

The posterior shelf 11, when present, provides an anatomical structurethat can be used advantageously for the anchorage of a prosthetictricuspid valve (as described further herein). When no such posterior,shelf is present (e.g., as shown in FIG. 5 ), robust anchorage of aprosthetic tricuspid valve at the site of the native tricuspid valve 10is more challenging. Nevertheless, and as described in U.S. patentapplication Ser. No. 17/747,507 filed on May 18, 2022) which is herebyincorporated by reference in its entirety and for all purposes), theprosthetic tricuspid valves described herein can be successfully used insuch a case.

FIGS. 6-8 illustrate an example prosthetic tricuspid valve 100 (orsimply “valve 100”) in accordance with some example embodiments of thisdisclosure. The valve 100 includes a frame 102 and a covering ICAattached to the frame 102. FIG. 7 shows the valve 100 engaged with anative tricuspid valve 10 between the right atrium and the rightventricle.

The frame 102 comprises a cellular structure that provides mechanicalsupport for the shape and structures of the valve 100. In someembodiments, the frame 102 is made from nitinol (NiTi), stainless steel,cobalt chromimum, MP35N, titanium, polymeric materials, otherbiocompatible materials, or any combination thereof. Some or all partsof the frame 102 may be covered by the covering 104. The frame 102 canbe made of a laser cut, expanded, and shape-set material in someembodiments. The frame 102 is self-expanding in some embodiments. Insome embodiments, the precursor material is tubular NiTi, a NiTi sheet,or other suitable types of precursor materials.

The covering 104 may made of a biocompatible polymer material (e.g.,expanded polytetrafluoroethylene (ePTFE), UHMWPE (ultra-high molecularweight polyethylene), nylon; polyester (e.g., DACRON), or anothersynthetic material), natural tissues (e.g., bovine, porcine, ovine, orequine pericardium), or any combination thereof. The covering 104 can beattached to the frame 102 by suturing, using clips, adhesives, and/orany other suitable attachment process.

The valve 100 includes a main body 106. The main body 106 includes anoccluder 110 (e.g., a one-way valve) that defines a central axis 101.The occluder 110 has flexible leaflets 111 a; 111 b, and 111 c(collectively 111 a-c) that cause the occluder 110 to function as aone-way valve (in a manner like a native tricuspid valve). The occluder110 defines a circular inlet where the edges of leaflets 111 a-c areattached to the frame 102. Other side edges of the leaflets 111 a-c areattached to posts 112 a, 112 b, and 112 c of the frame 102. The leaflets111 a-c also have distal free edges that are coaptable with each otherto facilitate the opening and sealing of the occluder 110.

The man body 106 of the valve 100 includes an inflow end portion 102 i,a mid-body portion 102 m, and an outflow end portion 102 o. The inflowend portion 102 i includes a series of arch shapes in the frame 102,circumscribing the axis 101 of the occluder 110. The occluder leaflets111 a-c allow blood to directionally flow through the occluder 110 fromthe inflow end portion 102 i to the outflow end portion 102 o. Theleaflets 111 a-c of the occluder 110 close against each other coapt) toprevent blood flow in the other direction (to prevent blood flow fromthe outflow end portion 102 o to the inflow end portion 102 i).

The embodiments of the valve 100 depicted in this disclosure employthree occluder leaflets 111 a-c, which is referred to as tri-leafletoccluder. The occluder 110 of the valve 100 can optionally employconfigurations other than a tri-leaflet occluder. For example,bi-leaflet, quad-leaflet, or mechanical valve constructs can be used insome embodiments. In particular implementations described herein, theflexible leaflets 111 a-c are made of natural tissues such as porcine orbovine or equine or ovine pericardium. In such embodiments, the tissuesare chemically cross-linked using glutaraldehyde or formaldehyde, orother aldehydes commonly used as crosslinking agents. In otherembodiments, the flexible leaflets 111 a-c are made of polymers such aspolyurethane, polyester (DACRON) or expanded polytetrafluoroethylene(ePTFE). In some embodiments, the flexible leaflets 111 a-c are attachedto structural frame 102 using sutures that could be made of materialsincluding but not limited to UHMWPE, nylon, or polyester (e.g., DACRON).

The valve 100 also includes a first anterior flap 120 a (or septalanterior flap 120 a), a second anterior flap 120 b (or lateral anteriorflap 120 b), and at least one posterior flap 130. The frame 102 and thecovering 104 combine to form the anterior flaps 120 a-b and theposterior flap 130. The frame 102 provides the structure of the anteriorflaps 120 a-b and the posterior flap 130, and the covering 104 providesocclusion. While the depicted embodiment includes two anterior flaps 120a-b, in some embodiments one, three, four, or more than four anteriorflaps can be included. While the depicted embodiment includes a singleposterior flap 130, in some embodiments two, three, four, or more thanfour posterior flaps can be included. For instance, FIG. 31 refers to anembodiment with two posterior flaps 330 a and 330 b.

The anterior flaps 120 a-b and the posterior flap 130 extend away fromthe outflow end portion 102 o of the main body 106 in oppositedirections away from the axis 101, That is, the posterior flap 130extends directionally opposite from the extension direction of the firstand second anterior flaps 120 a-b. In some embodiments, the posteriorflap 130 extends 180° opposite from the extension direction of the firstand second anterior flaps 120 a-b. In particular embodiments, theanterior flaps 120 a-b and the posterior flap 130 extend away from theoutflow end portion 102 o of the main body 106 transverse to the axis101 of the occluder 110.

In the depicted embodiment, the first anterior flap 120 a and the secondanterior flap 120 b each include a mid-body portion 124 (FIG. 6 ) thatis bent at an angle so as to direct terminal end portions of theanterior flaps 120 a-b toward the inlet end of the main body 106. Insome embodiments the anterior flaps 120 a-b initially extend away fromthe main body 106 substantially perpendicularly (e.g., within about 80°to 100°) to the central axis 101. Then, at the mid-body portion 124, theanterior flaps 120 a-b have a bend that defines an angle θ in a range ofbetween 20° to 60°, or 30° to 60°, or 30° to 70°, or 40° to 60°, or 40°to 70°, or 40° to 50°, without limitation.

The bends in the mid-body 106 of the anterior flaps 120 a-b can allowthe anterior flaps 120 a-b to conform to the contours of the wall thatdefines the RVOT (as shown in FIG. 7 ). Accordingly, the bent anteriorflaps 120 a-b can reduce the potential of the anterior flaps 120 a-b torestrict blood flow through the RVOT in some cases.

As shown in FIG. 8 , the depicted embodiment includes an opening 126 athat is defined by the covering 104 located at a terminal end portion ofthe first anterior flap 120 a. Additionally, the covering 104 on thesecond anterior flap 120 b defines an opening 121 b at a terminal endportion of the second anterior flap 120 b.

The openings 120 a-b in the end portions of the anterior flaps 120 a-ballow blood to flow through the anterior flaps 120 a-b (via the openings126 a-b). This can be beneficial because in some implementations theanterior flaps 120 a-b extend into the RVOT. Accordingly, such openings126 a-b may in some cases reduce the potential of the anterior flaps 120a-b to restrict blood flow through the RVOT.

In the depicted embodiment, the posterior flap 130 includes a firstportion 130 a and a second portion 130 b that are arranged at an anglein relation to each other. The first portion 130 a extends away from theoutflow end portion 102 o of the main body 106 generally transverse tothe axis 101 of the occluder 110. The second portion 130 b of theposterior flap 130 extends from the first portion 130 a In the depictedembodiment, the second portion 130 b extends generally parallel to theaxis 101 of the occluder 110. The angle defined between the firstportion 130 a and the second portion 130 b can be in a range of 80° to100°, or 70° to 110°, or 60° to 120°, or 50° to 130°, or 40° to 140°,without limitation.

The first anterior flap 120 a and the second anterior flap 120 b eachextend in the same direction, which is opposite of the direction thatthe posterior flap 130 extends. In the depicted embodiment, portions ofthe first anterior flap 120 a and the second anterior flap 120 b overlapeach other. An advantage of having the two separate anterior flaps 120a-b (rather than a single larger anterior flap) is that the anteriorflap portion of the valve 100 can be radially compressed to a smallerprofile for transcatheter delivery by the virtue of having the twoseparate anterior flaps 120 a-b (as compared to having a single largeranterior flap).

In some embodiments, as shown in FIG. 7 , the first and second anteriorflaps 120 a-b extend into the RVOT and overlap one axially on top of theother. This arrangement is functionally akin to a cantilevered beamarrangement. With the first and second anterior flaps 120 a-boverlapping on each other, the bending resistance of the first andsecond anterior flaps 120 a-b is increased (as compared to a single flapor non-overlapping flaps). This arrangement enables an advantageousextent of rigidity, without having to use framework members that arelarger in cross-section. That is, the overlapping arrangement of thefirst and second anterior flaps 120 a-b allow for the use of smallerframework members, which in turn importantly allows for a smallercollapsed delivery size (diameter). In other words, overlappingarrangement of the first and second anterior flaps 120 a-b provides asupport structure that is thicker without having to use a material withhigher wall thickness (from which the framework is created); ultimatelyproviding the bending stiffness or rigidity that keeps the valve 100stable when RV pressure acts on the valve 100.

In the depicted embodiment, an open passage 122 (e.g., see FIG. 16 ) isdefined between the first anterior flap 120 a and the second anteriorflap 120 b. The open passage 122 can be used, for example, for passing apacemaker lead through the valve 100, without disturbing the functioningof the occluder 110. Accordingly, the valve 100 can facilitate thepass-through of the pacemaker lead while still providing sealing toprevent tricuspid valve regurgitation from the RV to the RA. In somecases, the pacemaker lead is pre-existing and the valve 100 is implantedsubsequently (with the open passage 122 being used to receive thepacemaker lead). In other cases, the valve 100 can be pre-existing andthe pacemaker lead can be subsequently passed through the open passage122. This could take place both during the same implant procedure, or asa subsequent procedure.

FIG. 31 illustrates another example prosthetic valve 300. The valve 300defines an open passage 332 between the posterior flaps 330 a and 330 bthat can be used, for example, for passing a pacemaker lead through thevalve 300, without disturbing the functioning of the occluder 310. Insome cases, the pacemaker lead is pre-existing and the valve. 300 isimplanted subsequently (with the open passage 322 being used to receivethe pacemaker lead). In other cases, the valve 300 can be pre-existingand the pacemaker lead can be subsequently passed through the openpassage 322.

Still referring to FIGS. 6-8 , the valve 100 also includes one or moreleaflet engagement members 140. In the depicted embodiment, the valve100 includes two leaflet engagement members: a first leaflet engagementmember 140 a and a second engagement member 140 b. In the depictedembodiment, the leaflet engagement members 140 a-b extend from theoutflow end portion 102 o of the main body 106. In some embodiments, theleaflet engagement members 140 a-b extend from the mid-body portion 102m of the main body 106.

The leaflet engagement members 140 a-b extend from the frame 102 andbend toward the inflow end portion 102 i of the main body 106. In otherwords, a portion of each leaflet engagement member 140 a-b extendstoward the inflow end portion 102 i of the main body 106. A space,groove, or slot is defined between the leaflet engagement members 140a-b and the outer surface of the frame 102 (with the covering 104 beingpresent on the frame 102 and leaflet engagement members 140 a-b). Asdescribed further below, the space, groove, or slot receives andmechanically captures/holds a portion of a native leaflet (e.g., theposterior leaflet 11 p and/or the septal leaflet 11 s) to providemigration resistance for the valve 100.

In the depicted embodiment, the leaflet engagement members 140 a-bextend from the frame 102 of the main body 106 in the same direction asthe posterior flap 130. The posterior flap 130 extends away from themain body 106 farther than the leaflet engagement members 140 a-b.Various other arrangements of the leaflet engagement members 140 a-b andthe posterior flap 130 are also envisioned and within the scope of thisdisclosure.

The leaflet engagement members 140 a-b may be U-shaped wire loops, as inthe depicted embodiment. The wire loops that make up the leafletengagement members 140 a-b can be continuous with the wire members ofthe frame 102.

In the depicted embodiment, the leaflet engagement members 140 a-bterminate at free ends. Accordingly, the leaflet engagement members 140a-b point toward the inflow end portion 102 i of the main body 106, withthe free ends of the leaflet engagement members 140 a-b being theclosest to the inflow end portion 102 i. This arrangement defines thespace, groove, or slot receives and mechanically captures/holds aportion of a native leaflet to provide migration resistance for thevalve 100.

The depicted embodiment of the valve 100 includes an optional posteriorarm 150. The posterior arm 150 comprises a wire member. (e.g., anelongated loop) that extends from the frame 102 and includes a free end150 e (which can also be said to be located at a distal end portion ofthe posterior arm 150). In some embodiments, the posterior arm 150 is awire member that is constructed unitarily with wire members of the frame120. Hence, it can be said that the posterior arm 150 is a portion ofthe frame 120. In the depicted embodiment, the covering 104 is attachedto the posterior arm 150, including the free end 150 e.

In the depicted embodiment, the posterior arm 150 extends from theinflow end portion 102 i of the frame 102. The posterior arm 150 extendsin a direction that is the same as, or that is generally (e.g., +/−20°)parallel to, the direction in which the posterior flap 130 extends. Insome embodiments, the posterior arm 150 extends from the mid-bodyportion 102 m of the frame 102. The location of the free end 150 e iswithin a transverse plane (e.g., taken perpendicular to the axis 101)that intersects the mid-body portion 102 m of the frame 102 or theinflow end portion 102 i of the frame 102.

The posterior arm 150 provides as anchorage and migration resistance forthe valve 100. As depicted in FIG. 7 , the free end 150 e of theposterior arm 150 abuts against an anatomical structure when the valve100 is engaged in a native tricuspid valve 10. In some cases, the freeend 150 e of the posterior arm 150 abuts against an interior wall of aninferior vena cava, or coronary sinus, the right atrium, or anotheranatomical structure. Where it abuts can be largely a function of thevariable anatomy from patient to patient. The migration resistanceprovided by the posterior arm 150 can be particularly advantageousduring diastole when the occluder 110 is open to allow blood flow fromthe right atrium to the right ventricle via the occluder 110.

Referring also to FIG. 9 , in some embodiments the frame 102 can includean anterior arm 160. The anterior arm 160 may also be covered similarlyto the posterior arm 150. The anterior arm 160 comprises a wire member(e.g., an elongated loop) that extends from the frame 102 and includes afree end 160 e (which can also be said to be located at a distal endportion of the posterior arm 160). In some embodiments, the anterior arm160 is a wire member that is constructed unitarily with wire members ofthe frame 120. Hence, it can be said that the anterior arm 160 is aportion of the frame 120. In the depicted embodiment, the covering 104is attached to the anterior arm 160, including the free end 160 e.

In the depicted embodiment, the anterior arm 160 extends from the inflowend portion 102 i of the frame 102. The anterior arm 160 extends in ananterior direction away from the axis 101 (e.g., a direction that isgenerally the same as the direction in which the anterior flaps 120 a-bextend). In some embodiments, the anterior arm 160 extends from themid-body portion 102 m of the frame 102. The location of the free end160 e is within a transverse plane (e.g., taken perpendicular to theaxis 101) that intersects the mid-body portion 102 m of the frame 102 orthe inflow end portion 102 of the frame 102.

The anterior arm 160 provides additional anchorage and migrationresistance for the valve 100. The free end 160 e of the anterior arm 160abuts against an anatomical structure when the valve 100 is engaged in anative tricuspid valve 10. In some cases, the free end 160 e of theanterior arm 160 abuts against an interior well of a right atrialappendage or another anatomical structure. Where the anterior arm 160lands relative to the anatomy can vary based on patient to patientvariability. The migration resistance provided by the anterior arm 160can be particularly advantageous during diastole when the occluder 110is open to allow blood flow from the right atrium to the right ventriclevia the occluder 110.

Some embodiments of the valve 100 include the posterior arm 150 but notthe anterior arm 160. Other embodiments of the valve 100 include theanterior arm 160, but not the posterior arm 150. Still other embodimentsof the valve 100 include both the posterior arm 150 and the anterior arm160.

FIG. 10 schematically illustrates a transverse plane view of a nativetricuspid valve 10. The native tricuspid valve 10 includes the annulus12. The RVOT extends away from the native tricuspid valve 10 along anarcuate path.

FIG. 11 schematically illustrates a top view of the valve 100. The valve100 includes the main body 106, the occluder 110, the septal anteriorflap 120 a, the lateral anterior flap 120 b, the posterior flap 130, andthe posterior arm 150.

FIG. 12 schematically illustrates the valve 100 engaged in the anatomyof the native tricuspid valve 10 (that is also Illustrated in FIG. 10 ).In this illustration, it can be seen how the septal anterior flap 120 aand the lateral anterior flap 120 b extend into the RVOT. Moreover, itcan be seen that an edge of the lateral anterior flap 120 b abutsagainst and extends along a lateral wall 14 of the RVOT.

FIG. 13 schematically illustrates a cross-sectional view of the RVOT anddistal end portions of the anterior flaps 120 a-b. This cross-sectionalview is taken along the cutting plane 13-13 shown in FIG. 12 . It can beseen that the edge of the lateral anterior flap 120 b abuts against andengages with the anatomical topography of the lateral wall 14 of theRVOT. The interfacing relationship between the lateral anterior flap 120b and the lateral wall 14 of the RVOT provides anchorage and migrationresistance of the valve 100 relative to the native tricuspid valve 10.For example, there is a frictional migration resistance aspect providedby the normal forces exerted by the edge of the lateral anterior flap120 b against the lateral wall 14 of the RVOT. In addition, in someembodiments there is supplementary migration resistance provided becausethe edge of the lateral anterior flap 120 b can seat against certainanatomical topographical features of the lateral wall 14 of the RVOT. Insuch a case, the lateral wall 14 physically supports the lateralanterior flap 120 b and resists movement of the valve 10 relative to theanatomy of the native tricuspid valve 10 and RVOT. The interfacingrelationship between the lateral anterior flap 120 b and the lateralwall 14 of the RVOT provides anchorage and migration resistance of thevalve 100 relative to the native tricuspid valve 10 that is particularlybeneficial during diastole when the occluder 110 is open to allow bloodflow from the right atrium to the right ventricle via the occluder 110.

Referring again to FIG. 10 , the shape of the annulus 12 of manytricuspid valves 10 is not circular. Often, as depicted here, shape ofthe annulus 12 is oblong or ovoidal (oval shaped). That is, the distancebetween the posterior and anterior regions of the annulus 12 is longerthan the distance between the septal and lateral regions of the annulus12. Accordingly, it can be said that the annulus 12 defines a majordiameter 16 between the posterior and anterior regions, and a minordiameter 18 between the septal and lateral regions of the annulus 12.

Also referring again to FIG. 12 , in this embodiment of the valve 100,the main body 106 has an ovular outer cross-sectional shape. Incontrast, the occluder 110 within the main body 106 has a circularcross-sectional shape. The oval shaped main body 106 of the valve 100has a major diameter 108 and a minor diameter 109. The anterior flaps120 a-b and the posterior flap 130 extend from the main body 106 along adirection that is transverse to the major diameter 108 of the ovalshaped main body 106. In some embodiments, the anterior flaps 120 a-band/or the posterior flap 130 extend from the main body 106substantially orthogonally or perpendicularly (e.g., 90°+/−5°,90°+/−10°, 90°+/−15°, or 90°+/−20°,) to the major diameter 108 of theoval shaped main body 106.

In some embodiments, as depicted in FIG. 12 , the main body 106 issmaller than the full size/area of the annulus 12. Accordingly, theanterior flaps 120 a-b can be used to fill up the internal area definedthe annulus 12 that is not occupied by the main body 106. The occluder110 occupies a circular cross-sectional area that is smaller than thecross-sectional area main body 106, which is adequate for thehemodynamics of the blood flow between the atrium and the ventricle. Insome embodiments, the percentage of the internal area defined by theannulus 12 that is occupied by the main body 106 is about 50% (with theremaining about 50% of the area of the annulus 12 being covered by theanterior flaps 120 a-b). In some embodiments, the percentage of the areaof the annulus 12 that is occupied by the main body 106 is in a range ofabout 50% to 60%, or 55% to 65%, or 60%, to 70%, or 65% to 75%, or 70%to 80%, or 75% to 85%, or 60% to 80%, without limitation, with theanterior flaps 120 a-b covering the remainder of the area of the annulus12. In some embodiments, the anterior flaps 120 a-b cover at least 50%,or at least 40%, or at least 30%, or at least 20%, or at least 10%, orat least 5% of the internal area defined by the annulus 12.

The fact that the anterior flaps 120 a-b cover at least a portion of thearea defined within the annulus 12 can be beneficial for additionalreasons. For example, if, at some point in the future after the valve100 has been implanted in the annulus, 12, a pacemaker lead needs to bepassed through the annulus 12, then a location on the anterior flaps 120a -b can be punctured to allow the pacemaker lead to pass through theanterior flaps 120 a-b. The puncture can be at the open passage 122, orat another location of the anterior flaps 120 a-b. The ability to pass apacemaker lead through the anterior flaps 120 a-b is advantageousbecause doing so does not affect the functionality of the occluder 110.This is advantage is made possible by the fact that the anterior flaps120 a-b cover at least a portion of the area of the annulus 12.

Since, as depicted in the example of FIG. 12 , in some cases a portionof the oval shaped annulus 12 is covered by the anterior flaps 120 a-b,the main body 106 need not be circular, and can be constructed to havevarious types of cross-sectional shapes. An oval shape (as shown) may bepreferable in some cases, as it can be radially compressed well forfitting in a low-profile delivery catheter because it can have a smallerperimeter due to the minor diameter 109 of the main body 106 beingshorter than the major diameter 108. If, for example, the main body 106had a circular cross-sectional shape with a diameter equal to the majordiameter 108, the main body 106 could not be radially crushed/compressedto as small of a size as the depicted oval shaped main body 106. Hence,a larger delivery sheath would be required if the main body 106 wascircular (as compared to ovular as shown).

Interestingly, in the example depicted in FIG. 12 , while both theannulus 12 of the tricuspid valve 10 and the main body 106 of the valve100 are oblong or oval shaped, the orientations of their major and minordiameters are about 90° (e.g., 90°+/−10°) offset in relation to eachother when the valve 100 is implanted in the tricuspid valve 10. Thatis, the major diameter 108 of the oval shaped main body 106 issubstantially parallel (e.g., +/−10°) relative to the minor diameter 18of the annulus 12. Moreover, the minor diameter 109 of the oval shapedman body 106 is substantially parallel (e.g., +/−10°) relative to themajor diameter 16 of the annulus 12. These geometric relationships arebeneficial because the annulus 12 is fully occluded by the valve 100 andthe diameter of the radially compressed delivery configuration of thevalve 100 can be reduced (as compared to having the main body 106filling a larger area of the annulus 12).

Again, it is evident in FIG. 12 that the opening defined by the nativeannulus 12 is not completely filled by the main body 106. Instead, thelaterally-extending first and second anterior flaps 120 a-b help tocover and fluidly seal the native tricuspid valve opening which is notcircular in this example (e.g., with the native valve opening beingoblong, or irregularly shaped). In other words, in combination with themain body 106 of the valve 100, the first and second anterior flaps 120a-b (and the laterally-extending posterior anchoring flap 130 in somecases) help to cover and fluidly seal the native tricuspid valve openingwhich is not circular in some cases. In addition, terminal end portionsof the first and second anterior flaps 120 a-b extend into the RVOT toprovide anchoring and migration resistance. Accordingly, the first andsecond anterior flaps 120 a-b perform both sealing and anchorage.

In some cases, the shape of a patient's native annulus 12 is generallycircular. In such a case, the valve 100 can still provide much of thebenefits described above. For example, the main body 106 can still havean oblong or oval-shaped outer cross-sectional shape that occupies lessthan the full circular area of the native annulus 12 (with the first andsecond anterior flaps 120 a-b occupying the remainder). In that case,the valve 100 is implanted in the native annulus 12 such that thecentral axis 101 of the occluder 110 is laterally offset (e.g., in theposterior direction) from the geometric center of the generally circularnative annulus 12. In addition, the major diameter 108 of the main body106 can be shorter than the diameter of the native annulus 12. Forexample, in some embodiments the length of the major diameter 108 of themain body 106 is about 60% to 80% of the diameter of the native annulus12, or about 70% to 90% of the diameter of the native annulus 12, orabout 80% to 95% of the diameter of the native annulus 12, withoutlimitation.

FIG. 14 illustrates a longitudinal plane cross-section view (e.g.,approximately parallel to the central axis of the annulus 12) near ananterior portion of the native tricuspid valve annulus 12. This view isfrom the interface between the RVOT and the native tricuspid valveannulus 12, looking toward the right atrium and right ventricle. In thisview, it can be seen that the anterior annulus 12 is curved.

FIG. 15 shows an anterior end view of the frame 102 of the valve 100(without the covering 104 in this example). The first and secondanterior flaps 120 a-b are in the foreground in this view, and the mainbody 106 is in the background.

A heavy line 121 has been superimposed on FIG. 15 to represent thecross-sectional shape of the first and second anterior flaps 120 a-b(when the covering 104 is attached to the frame 102). It can be seenthat the cross-sectional shape of the first and second anterior flaps120 a-b (taken perpendicularly to the direction in which the first andsecond anterior flaps 120 a-b extend from the main body 106) is curvedor arcuate. The arc extends from the outflow end portion 102 o of theframe 102 toward the inflow end portion 102 i, with the middle of thearc being the closest point of the arc to the inflow end portion 102 i.

The curved or arcuate cross-sectional shape of the first and secondanterior flaps 120 a-b is beneficial because, as described in referenceto FIG. 14 , the anterior portion of the native tricuspid valve annulus12 with which the first and second anterior flaps 120 a-b interface isalso curved. Accordingly, a good sealing interface between the arcedfirst and second anterior flaps 120 a-b and the arced anterior portionof the native tricuspid valve annulus 12 is created by thesecomplimentary curved shapes. This sealing arrangement between the arcedfirst and second anterior flaps 120 a-b and the native tricuspid valveannulus 12 can be beneficial for mitigating paravalvular leaks when thevalve 100 is engaged with the native tricuspid valve 10.

As shown in FIG. 15 , in the depicted embodiment the arcuatecross-sectional shape of the first and second anterior flaps 120 a-b isat least partially facilitated by the configuration of frame portions128 a and 128 b (also visible in FIG. 9 ). The frame portions 128 a and128 b constitute interior parts of the outer edges of the first andsecond anterior flaps 120 a-b. The frame portions 128 a and 128 b arearranged at a non-zero angle in relation to the central axis 101 so asto help define the arcuate cross-sectional shape of the first and secondanterior flaps 120 a-b that is represented by the heavy line 121. Insome embodiments, the angle between the frame portions 128 a and 128 band the central axis 101 is between 20° to 50°, or between 30° to 80°,or between 40° to 70°, without limitation. The frame portions 128 a and128 b near the outer edges of the first and second anterior flaps 120a-b perform particularly advantageously to create good seals between thefirst and second anterior flaps 120 a-b and the anterior portion of thenative tricuspid valve annulus 12, because paravalvular leaks areparticularly prone to occur in those edge areas.

FIGS. 17 and 18 illustrate an example prosthetic heart valve deploymentsystem 200 (or simply “deployment system 200”). The deployment system200 includes a control handle 210, an outer sheath catheter 220, amiddle deflectable catheter 230. and an inner control catheter 240. Theouter sheath catheter 220 defines a first lumen. The middle deflectablecatheter 230 is slidably disposed in the first lumen and defines asecond lumen. The inner control catheter 240 is slidably disposed in thesecond lumen.

The inner control catheter 240 includes a curved portion 242. The curvedportion 242 is elastically deformable. That is, while the curved portion242 is located within the confines of the first lumen of the outersheath catheter 220, the curved portion 242 is essentially linear (or atleast more linear than when the curved portion 242 is radiallyunconstrained). When the curved portion 242 of the inner controlcatheter 240 is distally expressed out (either by pushing the innercontrol catheter 240 distally or by pulling the outer sheath catheter220 proximally) from the confines of the first lumen of the outer sheathcatheter 220, the curved portion 242 then naturally elasticallyreconfigures to exhibit a pronounced curve (e.g., as shown in FIG. 18 ).Thus, it can be said that the natural shape of the inner controlcatheter 240 includes the curved portion 242 that defines an interiorangle θ. In some embodiments, the interior angle θ can be between 130°and 160°, or between 120° and 150°, or between 110° and 140°, or between100° and 130°, or between 90° and 120°, or between 80° and 110°, orbetween 80° and 100°, without limitation. In some embodiments, theinterior angle θ can be less than 160°, or less than 150°, or less than140°, or less than 135°, or less than 130°, or less than 120°, or lessthan 110°, or less than 100°, or less than 90° without limitation.

The middle deflectable catheter 230 includes, a selectively deflectabledistal end portion 232 with at least one pane of deflection. In someembodiments, the selectively deflectable distal end portion 232 isdeflectable in two planes. In some embodiments, the middle deflectablecatheter 230 includes two or more separate selectively deflectableportions that are in same planes or in different planes.

In the depicted embodiment, the selectively deflectable distal endportion 222 is deflectable in a same plane as the pane of the curvedportion 242 of the inner control catheter 240. Accordingly, when theselectively deflectable distal end portion 232 of the middle deflectablecatheter 230 is deflected, the curvature of the combination of themiddle deflectable catheter 230 and the inner control catheter 240 inrelation to the axis of the outer sheath catheter 220 is increasedbeyond that of the interior angle θ alone. In some embodiments, thecombined curvature of the middle deflectable catheter 230 and the innercontrol catheter 240 in relation to the axis of the outer sheathcatheter 220 can define an interior angle between 90° and 110°, orbetween 80° and 100°, or between 70° and 90°, or between 60° and 80°, orbetween 50° and 70°, or between 30° and 60°, or between 0° and 30°,without limitation. This high degree of curvature can be beneficialduring deployment of a prosthetic valve (such as the valve 100) usingthe deployment system 200, as described further below.

The inner control catheter 240 can also include mechanical features forreleasably coupling with a prosthetic valve (such as the valve 100). Forexample, in the depicted embodiment, the inner control catheter 240includes one or more control wires and/or release pins 244 that canreleasably coupe the valve 100 to the inner control catheter 240 in alow profile delivery configuration.

FIG. 19 shows a schematic illustration of the valve 100. FIG. 20schematically shows the valve 100 coupled to the inner control catheter240 and located within the first lumen defined by the outer sheathcatheter 220. The distal tip of the middle deflectable catheter 230 isalso visible, in this arrangement, the valve 100 is radially compressedto a low-profile delivery configuration while within the outer sheathcatheter 220. In some embodiments, the valve 100 (or portions thereofare wrapped or folded around the inner control catheter 240. Forexample, in some embodiments the anterior flaps 120 a-b are wrappedaround the inner control catheter 24. The valve 100 can self-expand asits emergence from the outer sheath catheter 220 takes place (e.g., bythe manual retraction of the outer sheath catheter 220 relative to themiddle deflectable catheter 230 and the inner control catheter 240).

In some embodiments, when the valve 100 is in its collapsed deliveryconfiguration within the outer sheath catheter 220, the portions of thevalve 100 are arranged relative to each other as follows. The first andsecond anterior flaps 120 a-b (which can be wrapped on each other) aredistal-most. The occluder portion (or valve core) 110 with the flexibleleaflets is proximal-most within the outer sheath catheter 220. Theposterior anchoring flap 130 is arranged between the distal-most firstand second anterior flaps 120 a-b and the proximal-most occluder portion110.

The valve 100 can be releasably coupled to the inner control catheter240 using the one or more control wires and/or release pins 244 (FIG. 18). In some embodiments, a first control wire is releasably coupled to aproximal end portion of the main body 106, a second control wire isreleasably coupled to a distal end portion of the main body 106, and athird control wire is releasably coupled to the posterior flaps 120 a-b.The control wires can be tensioned to draw and maintain the associatedportion of the valve 100 radially inward to be snug against the innercontrol catheter 240. During deployment of the valve 100, the controlwires can be individually relaxed to allow the associated portion of thevalve 100 to expand elastically toward its natural expanded shape.

Still referring to FIG. 20 , in this delivery configuration the curvedportion 242 of the inner control catheter 240 is being constrained in anessentially linear configuration by the outer sheath catheter 220.However, when the inner control catheter 240 is expressed from the outersheath catheter 220 (or as the outer sheath catheter 220 is pulledproximally relative to the inner control catheter 240), the curvedportion 242 will become unconstrained and will elastically deflect toits natural curved configuration (e.g., as shown in FIG. 18 ). Thecurved configuration of the curved portion 242 is beneficial for thedeployment process of the valve 100 into engagement with a nativetricuspid valve 10, as described further below.

FIGS. 21-30 illustrate a series of steps for deploying a prostheticheart valve (such as the heart valve 100 described herein in any of itsvariations) using the heart valve deployment system 200. These figuresillustrate a trans-jugular vein approach to the native tricuspid valve10 (via the superior vena cava).

FIG. 21 shows a distal end portion of the deployment system 200 emerginginto the right atrium via the superior vena cava. The deployment system200 is being advanced over a guidewire that was installed previously.The valve 100 (not visible) is within the outer sheath catheter 220.

FIG. 22 illustrates the valve 100 (while the valve 100 is releasablycoupled to the inner control catheter 240) after the withdrawal of theouter sheath catheter 220 and/or the advancement of the inner controlcatheter 240 and the middle deflectable catheter 230. At this stage, thecurved portion 242 (not visible under the valve 100) has becomeunconstrained and has elastically deflected to its natural curvedconfiguration. The natural curved configuration of the curved portion242 facilitates the inner control catheter 240 to make a relativelytight turn within the right atrium to advance from the vena cava andthrough the annulus 12 of the native tricuspid valve 10 as depicted.

FIGS. 23 and 24 illustrate further advancement of the valve 100 (whilethe valve 100 is still releasably coupled to the inner control catheter240). In these images, the middle deflectable catheter 230 is beingdeflected (by a first amount in FIG. 23 and a greater amount in FIG. 24). The deflection of the middle deflectable catheter 230 adds to thecurvature of the inner control catheter 240 to enable the distal endportion of the inner control catheter 240 to become directed toward theRVOT after passing through the annulus 12 (as shown in FIG. 24 ).

FIGS. 25 through 27 illustrate the release process of the portions ofthe valve 100 from the inner control catheter 240. As the portions ofthe valve 100 are released, those portions become engaged in thetargeted native anatomical locations. The control wires and/or releasepins for the anterior flaps 120 a-b and the posterior flap 130 arereleased (as best seen in FIG. 26 ). In response, the anterior flaps 120a-b deploy into the RVOT and the posterior flap 130 deploys to theposterior area of the tricuspid valve 10 just inferior to the annulus12. In addition, as the posterior flap 130 deploys, the one or moreleaflet engagement members 140 become coupled with the posterior leaflet11 p and/or the septal leaflet 11 s to provide migration resistance forthe valve 100. At this stage, the posterior arm 150 and/or the anteriorarm 160 (FIGS. 6-9 ) can also be deployed if the valve 100 includes aposterior arm 150 and/or an anterior arm 160. FIG. 27 shows the releaseof control wires that are coupled to the main body 106. In response, themain body 106 radially expands into contact and engagement with theannulus 12.

FIGS. 28 through 30 illustrate withdrawal of the deployment system 200.When the control wires, are disengaged from the valve 100, the innercontrol catheter 240 and the middle deflectable catheter 230 can then bewithdrawn, leaving the valve 100 engaged with the anatomy in and aroundthe native tricuspid valve 100.

FIG. 31 illustrates, another example prosthetic heart valve 300. Thevalve 300 is similar to the valve 100 described above; but is modifiedto be better suited for trans-femoral delivery (via the inferior venacava) to the native tricuspid valve 10.

The valve 300 includes an ovular main body 306 that contains a circularoccluder 310 that defines a central axis 301. The occluder 310 extendsbetween an inflow end and an outflow end portion of the main body 306,and includes valve leaflets in an arrangement that: (i) allows bloodflow through the occluder 310 in a direction from the inflow end portiontoward the outflow end portion along a central axis 301 of the occluder310 and (ii) prevents blood flow through the occluder 310 in a directionfrom the outflow end portion toward the inflow end portion. The valve300 also includes a first anterior flap 320 a extending from the outflowend portion of the main body 306 in a first direction that is transverseto the central axis 301, and a second anterior flap 320 b also extendingfrom the outflow end portion in the first direction. The valve 300 alsoincludes a first posterior flap 330 a extending from the outflow endportion of the main body 306 in a second direction that is opposite ofthe first direction, and a second posterior flap 330 b also extendingfrom the outflow end portion in the second direction. A passageway 332(e.g., for a pacemaker lead as described above) is defined between thefirst and second posterior flaps 330 a-b. In contrast to the valve 100,the first and second posterior flaps 330 a-b of the valve 300 extendfrom the outflow end portion of the main body 306 farther (a greaterdistance) than the first and second anterior flaps 320 a-b. Thisarrangement biases the main body 306 toward the anterior portion of theannulus 12 (refer to FIG. 10 ), which is different from the valve 100which is biased toward the posterior portion of the annulus 12 (refer toFIG. 12 ).

FIGS. 32-37 schematically illustrate a series of steps for deploying theheart valve 300 (as described herein in any of its variations) into theheart 1 using the heart valve deployment system 200 (e.g., refer toFIGS. 17 and 18 ). These figures illustrate a trans-femoral veinapproach to the native tricuspid valve 10 (via the inferior vena cava;“IVC”).

FIG. 32 illustrates the advancement of the deployment system 200 towardthe right atrium (“RA”) via the IVC. The outer sheath catheter 220(containing the heart valve 300 in its low-profile deliveryconfiguration) can be advanced over a previously placed guidewire thatextends into the right ventricle (“RV”) via the native tricuspid valve10.

FIG. 33 illustrates the emergence in the RA of the heart valve 300 fromthe outer sheath catheter 220 (e.g., by pulling the outer sheathcatheter 220 proximally and/or by distally advancing the middledeflectable catheter 230 and inner control catheter 240).

FIGS. 34 and 35 illustrate the advancement of the heart valve 300 intoposition for engagement with the native tricuspid valve 10. Toaccomplish this, the middle deflectable catheter 230 and inner controlcatheter 240 are both curved. That is, the inner control catheter 240 isnaturally curved because of its curved portion 242, and the middledeflectable catheter 230 is selectively deflected by a clinicianoperator who is performing the procedure.

FIG. 36 illustrates the release of the heart valve 300 from the innercontrol catheter 240, and the resulting expansion/deployment of theheart valve 300 into engagement at the location of the native tricuspidvalve 10. The release of the various components/regions of the heartvalve 300 can be performed in a controlled manner by manual manipulationof the one or more control wires and/or release pins 244 (FIG. 18 ) bythe clinician operator. The release of the heart valve 300 from theinner control catheter 240 results in the expansion of the main body306, the anterior flaps 320 a-b, and the posterior flaps 330 a-b intoengagement with the anatomy of the native tricuspid valve 10, the RV,and the RVOT.

Lastly, FIG. 37 illustrates the implanted heart valve 300 in engagementwith the heart 1 and functioning as a prosthetic tricuspid valve betweenthe RA and the RV. The deployment system 200 and guidewire have beenwithdrawn. It can be seen here (and in the top view of FIG. 31 ) thatthe heart valve 300 is positioned such that the main body 306 ispositionally biased toward the anterior portion of the annulus 12 (referto FIG. 10 ), which is adjacent the RVOT. Accordingly (and as shown inFIG. 31 ), the laterally-extending first and second posterior flaps 330a-b help to cover and fluidly seal the native tricuspid valve openingwithin the annulus 12, which is not circular in this example (e.g., withthe native valve opening being oblong, oval, or irregularly shaped). Inother words, in combination with the main body 306 of the valve 300, thefirst and second posterior flaps 330 a-b (and, in some cases, thelaterally-extending anterior anchoring flaps 320 a-b to a lesser extent)help to cover/occlude and fluidly seal the native tricuspid valveopening which is not circular in some cases. In addition, the endportions of the first and second posterior flaps 330 a-b extend intoengagement with the posterior shelf 11 (FIG. 4 ) and/or with the wall ofthe RV just inferior to the annulus 12 to provide anchoring andmigration resistance. Accordingly, the first and second posterior flaps330 a-b perform both sealing and anchorage.

FIGS. 38-40 illustrate the frame 102 that can be used in someembodiments of the prosthetic heart valves described herein. The frame102 has a cellular construction that provides mechanical support for theshape and structures of the prosthetic heart valves. In someembodiments, the frame 102 is made from nitinol (NiTi), stainless steel,cobalt chromimum, MP35N, titanium, polymeric materials, otherbiocompatible materials, or any combination thereof. Some or all partsof the frame 102 may be covered (e.g., by the covering 104 describedabove). In some embodiments, the frame 102 can be made of a laser cut,expanded, and shape-set material. The frame 102 is self-expanding insome embodiments. In some embodiments, the precursor material is tubularNiTi, a NiTi sheet, or other suitable types of precursor materials.

In this example, the frame 102 includes the optional posterior arm 150with the free end 150 e. The posterior arm 150 can also be referred toas a “diastolic anchoring tab,” because the posterior arm 150 helps toprevent migration of the prosthetic heart valve toward the rightventricle during diastole. In this example, the frame 102 does notinclude the anterior arm 160 (e.g., see FIG. 9 ). However, in someembodiments the anterior arm 160 is included as part of the frame 102.

In this example, the frame 102 does not include the frame portions 128 aand 128 b (e.g., see FIG. 9 ). However, in some embodiments the frameportions 128 a and 128 b are included as part of the frame 102.

As best seen in FIG. 40 , the frame 102 includes an inflow end portion102 i and an outflow end portion 102 o. In the depicted embodiment, thecellular structure of the inflow end portion 102 i and an outflow endportion 102 o differ from each other. In particular, the size of thecells that make up the inflow end portion 102 i are smaller than thesize of the cells that make up the outflow end portion 102 o. Forexample, the cells of the inflow end portion 102 i have a shorterlongitudinal length (e.g., measured longitudinally parallel to thelongitudinal axis 101) than the cells of the outflow end portion 102 o.Said another way, the cells of the outflow end portion 102 o are longerwhen measured along the longitudinal direction of the frame 102 than thecells of the inflow end portion 102 i.

The differences in the sizes of the cells of the inflow end portion 102i as compared to the cells of the outflow end portion 102 o causes theframe 102 to advantageously have different structural characteristicsalong the longitudinal length of the frame 102. For example, the inflowend portion 102 i of the frame 102 is structurally stiffer than theoutflow end portion 102 o, particularly as related to radially directedforces. Conversely, the outflow end portion 102 o of the frame 102 isstructurally more flexible than the inflow end portion 102 i. Moreover,the structures of the anterior flaps 120 a-b are very flexible becauseof the anterior flaps 120 a-b are primarily made of large open areaswithin peripheral frame members (e.g., see FIG. 39 ).

It can be advantageous for the inflow end portion 102 i of the frame 102to be structurally stiff. For example, such stiffness can help tomaintain the circular cross-sectional shape of the occluder of theprosthetic valve (e.g., the occluder 110 shown in FIGS. 6-8 ) while theheart muscle contracts to pump blood. Keeping such a circularcross-sectional shape of the occluder can serve to ensure that theleaflets of the occluder maintain their relative orientations in apredictable way. This can beneficially provide robust coaptation betweenthe leaflets to mitigate the occurrence of regurgitation through theoccluder, for example.

It can be advantageous for the outflow end portion 102 o of the frame102 and the anterior flaps 120 a-b to be structurally flexible. Forexample, such flexibility can beneficially mitigate the amount of forcefrom the frame 102 that is exerted onto the anatomy of the heart. Inparticular, having a flexible outflow end portion 102 o and flexibleanterior flaps 120 a-b reduces or eliminates forces from the frame 102from being applied to certain sensitive anatomical areas such as the AVnode, the right coronary artery, and the annulus of the heart valve, toprovide a few examples.

FIGS. 41-43 illustrate another example frame 102′ that can be used insome embodiments of the prosthetic heart valves described herein. Thisembodiment is different from the frame 102 in that the frame 102′includes the frame portions 128 a and 128 b and does not include theposterior arm 150 (and also does not include an anterior arm 160). Itshould be understood that such features can be mixed and matched in anydesired combination.

The frame 102′ shares the cell-size characteristics of the frame 102 asdescribed above. That is, the cells that make up the inflow end portion102 i are smaller and stiffer than the cells that make up the outflowend portion 102 o. The cells of the anterior flaps 120 a-b have thelargest size (making them the most flexible portion of the frame 102′).

Alternative methods of achieving the variable stiffness characteristicsdescribed above are also contemplated. For example, the strut widthsand/or thicknesses of different portions of the frame 102 could bedifferent.

While this specification contains many specific implementation details,these should not be construed as limitations on the scope of anyinvention or of what may be claimed, but rather as descriptions offeatures that may be specific to particular embodiments of particularinventions. Certain features that are described in this specification inthe context of separate embodiments can also be implemented incombination in a single embodiment in part or in whole. Conversely,various features that are described in the context of a singleembodiment can also be implemented in multiple embodiments separately orin any suitable subcombination. Moreover, although features may bedescribed herein as acting in certain combinations and/or initiallyclaimed as such, one or more features from a claimed combination can insome cases be excised from the combination, and the claimed combinationmay be directed to a subcombination or variation of a subcombination.

Similarly, while operations are depicted in the drawings in a particularorder, this should not be understood as requiring that such operationsbe performed in the particular order shown or in sequential order, orthat all illustrated operations be performed, to achieve desirableresults. Although a number of implementations have been described indetail above, other modifications are possible. For example, the stepsdepicted in the figures do not require the particular order shown, orsequential order, to achieve desirable results. In addition, other stepsmay be provided, or steps may be eliminated, from the described flows,and other components may be added to, or removed from, the describedsystems. Accordingly, other implementations are within the scope of thefollowing claims.

What is claimed is:
 1. A prosthetic heart valve comprising: a main bodycomprising an inflow end portion and an outflow end portion; an occluderextending between the inflow end and outflow end portions and comprisingvalve leaflets attached to the main body in an arrangement that: (i)allows blood flow through the occluder in a direction from the inflowend portion toward the outflow end portion along a central axis of theoccluder and (ii) prevents blood flow through the occluder in adirection from the outflow end portion toward the inflow end portion; afirst anterior flap extending from the outflow end portion in a firstdirection that is transverse to the central axis; and a second anteriorflap extending from the outflow end portion in the first direction,wherein a cross-sectional shape of the first and second anterior flapstaken perpendicularly to the first direction is arcuate from an outeredge of the first anterior flap to an outer edge of the second anteriorflap.
 2. The prosthetic heart valve of claim 1, wherein the first andsecond anterior flaps include frame portions extending from the outeredges of the first and second anterior flaps that are arranged at anon-zero angle in relation to the central axis so as to define at leasta portion of the arcuate cross-sectional shape.
 3. The prosthetic heartvalve of claim 2, wherein the frame portions are located adjacent themain body.
 4. The prosthetic heart valve of claim 2, wherein each of theframe portions comprise: two elongate members extending in the firstdirection: and multiple members extending between the two elongatemembers.
 5. The prosthetic heart valve of claim 1, wherein portions ofthe first and second anterior flaps overlap each other.
 6. Theprosthetic heart valve of claim 1, wherein an open space is definedbetween the first and second anterior flaps.
 7. The prosthetic heartvalve of claim 1, further comprising a posterior flap extending from theoutflow end portion in a second direction that is opposite of the firstdirection.